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Tyshak Mini
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref PDC409Model 107Ref PDC060Model 102Ref PDC408Ref PDC407Ref SO101Ref PDC405Ref PDC406Ref PDC402Ref PDC400510(k) K032591Ref SO102Ref SO103Ref PDC401Ref PDC127Ref PDC126Ref PDC084
by NuMED, Inc.
Identity
- Trade Name
- Tyshak Mini EUDAMEDTyshak EUDAMED
- Device Name
- Tyshak Mini EUDAMEDTyshak EUDAMED
- Model / Reference
- 107 EUDAMEDPDC409 EUDAMED102 EUDAMEDPDC060 EUDAMEDPDC408 EUDAMEDPDC407 EUDAMEDSO101 EUDAMEDPDC405 EUDAMEDPDC406 EUDAMEDPDC402 EUDAMEDPDC400 EUDAMEDSO102 EUDAMEDSO103 EUDAMEDPDC401 EUDAMEDPDC127 EUDAMEDPDC126 EUDAMEDPDC084 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714012188 EUDAMED10887714011204 EUDAMED10887714012171 EUDAMED10887714012317 EUDAMED10887714012256 EUDAMED10887714012300 EUDAMED10887714012164 EUDAMED10887714012249 EUDAMED10887714012201 EUDAMED10887714012270 EUDAMED10887714012294 EUDAMED10887714012225 EUDAMED10887714011884 EUDAMED10887714011792 EUDAMED10887714011358 EUDAMED
- Basic UDI-DI
- B-10887714012188 EUDAMEDB-10887714011204 EUDAMEDB-10887714012171 EUDAMEDB-10887714012317 EUDAMEDB-10887714012256 EUDAMEDB-10887714012300 EUDAMEDB-10887714012164 EUDAMEDB-10887714012249 EUDAMEDB-10887714012201 EUDAMEDB-10887714012270 EUDAMEDB-10887714012294 EUDAMEDB-10887714012225 EUDAMEDB-10887714011884 EUDAMEDB-10887714011792 EUDAMEDB-10887714011358 EUDAMED
- 510(k) Number
- K032591 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
- EMDN Code
- C019014 CARDIAC VALVULOPLASTY CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tyshak Mini by NuMED, Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032591 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-10887714012188 | Class III | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
- EUDAMED SRN
- US-MF-000010948
- Authorised Representative
- EVOMED S.L.U. ES-AR-000047116
Sources (16)
- EUDAMED d8a67933-9090-4089-9cf3-ad13ab21a924 61 fields · synced Sep 18, 2026
- EUDAMED 54774b8a-d03b-423a-8557-cda5cf8c96b7 61 fields · synced May 16, 2026
- EUDAMED 214f46b1-6f9a-4758-86dd-8939a709b46f 61 fields · synced May 16, 2026
- EUDAMED 38bf2af7-5652-468c-82f3-0eefa1eee1f2 61 fields · synced May 16, 2026
- EUDAMED a5140fa6-4dbd-42ec-95c8-d3b56ec69098 61 fields · synced May 17, 2026
- EUDAMED 01b2e7ef-1474-43a8-91db-19dd9303129f 61 fields · synced May 17, 2026
- EUDAMED 43b81cf7-8aa7-4dfb-a89a-f946c711e297 61 fields · synced May 17, 2026
- EUDAMED 01f1bcb4-32ba-40bf-899a-34a0576b88be 61 fields · synced May 18, 2026
- EUDAMED a78749b0-7e2b-4a5b-b1ab-f157df94fc17 61 fields · synced May 18, 2026
- FDA 510(k) K032591 24 fields · synced May 18, 2026
- EUDAMED faab1dd4-2608-488c-b537-4d5f0b3b2cce 61 fields · synced Jul 9, 2026
- EUDAMED 84d62a3b-8e7b-4fd7-82e5-2df4b90c9b46 61 fields · synced Jul 17, 2026
- EUDAMED 475603cf-83ef-40a6-9670-16ee4bd7273d 61 fields · synced Aug 4, 2026
- EUDAMED 13b33dbd-90c5-4883-87af-2134b7639a33 61 fields · synced Sep 17, 2026
- EUDAMED 7fea4984-e51d-47b9-8599-4cad8776cc8a 61 fields · synced Sep 18, 2026
- EUDAMED ff84f547-0674-45c3-8b00-a76fd5c1b065 61 fields · synced Sep 18, 2026